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Cimetidine Biowaivers

NCT01256879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-28

Study results available
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Summary

The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

Conditions

  • Healthy

Interventions

DRUG

Drug: cimetidine

cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • James Polli, PhD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256879 on ClinicalTrials.gov